A Biomarker Study to Predict Treatment Outcomes of Enfortumab Vedotin in Advanced Urothelial Carcinoma

N/AActive Not RecruitingNCT07063758

National Taiwan University Clinical Trial Center200 enrolled

Overview

This study aims to find biological markers that help predict how patients with advanced urothelial carcinoma respond to treatment with enfortumab vedotin (EV) or EV-based combination therapies. Since EV can cause significant side effects and is costly, identifying markers such as nectin-4 and related proteins in tumor tissue and blood may help doctors personalize treatment plans. The investigators will enroll about 100 patients receiving EV and compare them to another 100 patients treated with standard chemotherapy. By studying tissue samples and blood at different times, the investigators hope to discover which markers best indicate treatment success or risks. This research could lead to better, safer treatments tailored to each patient's biology.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Advanced Urothelial Carcinoma

Interventions

Biomarker AnalysisOTHER

Tumor tissue and serum samples will be collected and analyzed to evaluate the expression of membranous Nectin-4, ADAM10/17, and levels of soluble Nectin-4 (sNectin-4) as predictive biomarkers in patients with advanced urothelial carcinoma receiving standard therapies.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 20 y/o 2. Histologically confirmed urothelial carcinoma 3. Radiologically documented locally advanced or metastatic disease 4. Exposure to EV (as monotherapy or in combination with pembrolizumab) or first-line platinum-based chemotherapy 5. Complete and identifiable medical records Exclusion Criteria: 1. Inadequate or insufficient tumor tissues for analyses 2. Incomplete medical records

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Proportion of patients achieving complete or partial tumor response according to RECIST 1.1 criteria after enfortumab vedotin treatment.

Time frame: Up to 12 months after treatment initiation

Secondary Outcomes

Progression-Free Survival (PFS)

Time from treatment start to disease progression or death from any cause.

Time frame: Up to 24 months

Overall Survival (OS)

Time from treatment initiation to death from any cause.

Time frame: Up to 36 months

Treatment-Related Adverse Events

Incidence and severity of adverse events graded by CTCAE v5.0 during treatment.

Time frame: Up to 36 months

Association of Nectin-4, ADAM10/17 Expression and Serum Soluble Nectin-4 with Overall Survival, Progression-Free Survival, Objective Response Rate, and Adverse Events

To evaluate the correlation between baseline membranous Nectin-4 expression, ADAM10/17 expression (by immunohistochemistry), and serum soluble Nectin-4 levels (by ELISA) with clinical outcomes, including: Overall survival (OS) Progression-free survival (PFS) Objective response rate (ORR) assessed by RECIST v1.1 Treatment-related adverse events graded by CTCAE v5.0

Time frame: Assessed at baseline and up to 36 months